Topic: Life sciences and healthcare

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FCA upholds Gilead victory invalidating Idenix patent relating to anti-HCV compounds

In a brief decision, the Federal Court of Appeal dismissed Idenix’s appeal of a Federal Court decision which found that a patent owned by Idenix and purporting to claim anti-HCV compounds was invalid for: (i) failing to sufficiently disclose a synthetic method by which the claimed compounds could be made; and (ii) for lack of … Continue reading

Mid-year roundup – 2017

Hard to believe, but we are halfway through 2017 already! It has been a busy six months, with major developments, including Canada preparing to implement CETA and the Supreme Court of Canada abolishing the “Promise Doctrine.” Below, Pharma in Brief has compiled the top headlines so far this year. The Big Three: Utility and the … Continue reading

Sections of Vanessa’s Law regulating drugs for urgent public health need come into force

On July 12, 2017, section 5 and subsections 6(3) and 6(4) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) came into force. These sections amend the Food and Drugs Act to require healthcare institutions to report serious adverse drug reactions and permit the Governor in Council to make regulations that specify what this … Continue reading

“Promise Doctrine” rejected as a basis for invalidating patents for lack of utility in landmark Supreme Court of Canada ruling

The “Promise Doctrine” has been conclusively rejected by Canada’s highest court as a basis for invalidating a Canadian patent. In a judgment that reverses years of jurisprudence in the lower courts, the Supreme Court of Canada today held that the level of utility required of a Canadian patent must not be measured by statements in … Continue reading

CETA tracker: CETA Bill C-30 receives royal assent to implement pharmaceutical patent reform

It’s official – the Canadian government has approved the changes to Canada’s pharmaceutical patent regime. On May 16, 2017, Bill C-30 (the act intended to implement CETA into Canadian law) received royal assent, the final stage of the legislative process. Treaty/Act:        CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada … Continue reading

Proposed regulations published on additional elements of Vanessa’s Law

On April 22, 2017, the Government of Canada published draft regulations Amending the Food and Drug Regulations (Vanessa’s Law) that provide details regarding the minister of health’s powers to require tests, assessments and studies of a drug post-market authorization. The draft regulations also set out additional reporting requirements for manufacturers based on the actions of … Continue reading

CETA tracker: patent term restoration is coming soon to Canada – what you need to know now

Treaty/Act: CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States and to provide for certain other measures) With Canada moving closer towards implementing the Comprehensive Economic and Trade Agreement (CETA), major reforms to Canada’s Patent Act are coming soon, including the availability … Continue reading

Supreme Court dismisses leave to appeal regarding test for obviousness-type double patenting in tadalafil s.6 case

Case: Apotex Inc v Eli Lilly Canada Inc, et al (SCC Docket 37368) Drug: CIALIS® (tadalafil) Nature of case: Application for leave to appeal decision upholding prohibition order granted pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations) Successful party: Eli Lilly Canada Inc. and ICOS Corporation (collectively Eli Lilly) Date of decision: April … Continue reading

Health Canada proposes regulations allowing importation of drugs not yet available in Canada for an urgent public health need

Health Canada has proposed regulations that will amend the Food and Drug Regulations to allow for importation of drugs that have not yet received regulatory approval from Health Canada. The new regulations will provide access to drugs that address an urgent public health need provided they have been approved in the United States, the European … Continue reading

Federal Court of Appeal revisits obviousness: guidance provided on “inventive concept” and “obvious to try” test

Case: Bristol-Myers Squibb Canada Co v Teva Canada Limited, 2017 FCA 76 (A-191-16), aff’g (for different reasons) 2016 FC 580 (Court File No. T-1364-14) Drug: REYATAZ® (atazanavir bisulfate) Nature of case: Appeal from application for prohibition order granted pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations) Successful party: … Continue reading

FCA finds no failure to mitigate Apotex damages claim against Health Canada for delayed Apo-Trazodone NOC

Case: Apotex Inc v Her Majesty the Queen, 2017 FCA 73 (Court File No. A-553-14/A-554-14) Drug: Apo-Trazodone Nature of case: Appeal of action for damages in tort and breach of contract Successful party: Apotex Inc. (in part) Date of decision: April 6, 2017 Summary The Federal Court of Appeal allowed Apotex’s appeal, in part, from … Continue reading

Federal Court comments on the admissibility of ‘but for’ world s. 8 evidence and rejects generic pipefill claim

Case:  Eli Lilly Canada Inc et al v Teva Canada Limited, 2017 FC 88 Drug:  ZYPREXA® (olanzapine) Nature of case: Action pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations) Successful party: Teva Canada Limited Date: April 4, 2017 (public reasons) Summary The Federal Court established the parameters to … Continue reading

Current directions in regulatory and intellectual property law in Canadian pharmaceutical cases

Recent pharmaceutical cases in regulatory and intellectual property law have resulted in developments on several fronts, including: regulatory matters; patent validity and damages; Patented Medicines (Notice of Compliance) Regulations proceedings; and class actions. In this paper, we review some of the most notable Canadian decisions from 2015 that will continue to impact the legal landscape … Continue reading

Pharma in brief – TMOB dismisses section 45 proceedings for the trade-mark REMODULIN

Case: Blake, Cassels & Graydon LLP v United Therapeutics Corporation, 2017 TMOB 9 Trade-Mark: REMODULIN Nature of case: Summary expungement proceedingpursuant to section 45 of Trade-marks Act Successful party: United Therapeutics Corporation Date of decision: January 26, 2017 Summary The Trademarks Opposition Board (TMOB) accepted United Therapeutics Corporation’s evidence of use of the trade-mark REMODULIN … Continue reading
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